Ixifi Caution For Usage





Zuellig Pharma
Full Prescribing Info
Caution For Usage
Incompatibilities: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Ixifi with other agents. Ixifi should not be infused concomitantly in the same IV line with other agents.
Special precautions for disposal and other handling: General Considerations and Instructions for Preparation and Administration: Ixifi is intended for use under the guidance and supervision of a physician. The reconstituted infusion solution should be prepared by a trained medical professional using aseptic technique by the following procedure: 1. Calculate the dose, total volume of reconstituted Ixifi solution required and the number of Ixifi vials needed. Each Ixifi vial contains 100 mg of the infliximab antibody.
2. Reconstitute each Ixifi vial with 10 mL of Sterile Water for Injection, USP, using a syringe equipped with a 21-gauge or smaller needle as follows: Remove the flip-top from the vial and wipe the top with an alcohol swab. Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual. Allow the reconstituted solution to stand for 5 minutes. The solution should be colorless to light brown and opalescent, and the solution may develop a few translucent particles as infliximab is a protein. Do not use if the lyophilized cake has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 6.
3. Dilute the total volume of the reconstituted Ixifi solution dose to 250 mL with sterile 0.9% Sodium Chloride Injection, USP, by withdrawing a volume equal to the volume of reconstituted Ixifi from the 0.9% Sodium Chloride Injection, USP, 250 mL bottle or bag. Do not dilute the reconstituted Ixifi solution with any other diluent. Slowly add the total volume of reconstituted Ixifi solution to the 250 mL infusion bottle or bag. Gently mix. The resulting infusion concentration should range between 0.4 mg/mL and 4 mg/mL.
4. The Ixifi infusion should begin within 3 hours of reconstitution and dilution. The infusion must be administered over a period of not less than 2 hours and must use an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 μm or less). The vials do not contain antibacterial preservatives. Therefore, any unused portion of the infusion solution should not be stored for reuse.
5. Parenteral drug products should be inspected visually before and after reconstitution for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particulates are observed, the solution should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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